LSJ.pdf

General Services Administration Federal Supply Schedule Limited Source Justification

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

Health and Human Services (HHS)/Food and Drug Administration (FDA)/Office of Operations (OO)/Office of Finance, Budget, and Acquisitions (OFBA)/Office of Acquisitions and Grant Services (OAGS)/Division of Information Technology Acquisitions (DITA)

b. Sponsoring organization.

FDA/Center for Drug Evaluation and Research (CDER)/Office of Strategic Programs (OSP)/Office of Business Informatics (OBI)

c. Contracting Officer’s Representative (COR)/Requiring Activity Point of Contact (POC) information.

i. Name: Monica Lathan-Dye

ii. Mailing address: 10903 New Hampshire Ave., Silver Spring, MD 20993

iii. E-mail address: Monica.lathan@fda.hhs.gov

iv. Telephone number:202-431-3824

2. Nature and/or description of the action being approved.

The nature and purpose of this document is to delineate in writing the justification and approval (J&A) of a Limited Source modification to the Deloitte Drug Safety Workflow Management (WFM) Initiatives task order in accordance with the Federal Acquisition Regulation 8.405-6 .

The need exists to increase the level of effort of in support on the current Deloitte Drug Safety WFM task order. This work supports Office of Surveillance and Epidemiology ’s (OSE) needs for automation of workload management and business process which is an important priority. As OSE’s staff continues to increase substantially, increased capacity and complexity of informatics support for program management is needed. The current OSE work tracking system, Agency Information Management System (AIMS), is a legacy system that is not well positioned to meet OSE’s growing needs and does not meet CDER’s security standards. A waiver has been granted to continue using AIMS temporarily, so there is a need to build a modernized OSE workload tracking system adhering to FDA security and CDER modernization guidelines so that the OSE project managers and reviewers can continue to do their day-to-day job duties.

The work is already being performed by Deloitte on their Drug Safety WFM task order and this work aligns tightly to that effort. To compete this effort and award the development of the use case to a second vendor would create confusion on which vendor is doing what work, and how would we split establishing lines of responsibility between two vendors who are essentially performing the same tasks.

Separating this use case from the current work would potentially result in performance issues as the work is logically coupled. Deloitte was originally awarded this effort based on a stronger technical approach and their resources having the best suited skills and experience to successfully accomplish this work.

Another major concern is if this work was competed and went to a new vendor, there will be significant delays to even beginning the work as the onboarding process for a new contractor is taking anywhere from 8-12 weeks on average which may also result in an under burn and inability to meet all the required tasks in the necessary timeframe. On top of that, there is a major learning curve and the need for some employees to get elevated admin accounts and we are looking at months before work could really commence.

a. Acquisition purpose and objectives.

The objective of this task order is to help meet the mandates of legislation such as Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BsUFA), Generic Drug User Fee Act (GDUFA), Food and Drug Administration Safety and Innovation Act (FDASIA), and 21st Century Cures. The task order will support risk-based safety monitoring work processes implemented in the CDER Informatics Environment and support the FDA in meeting performance goals and commitments to regulated industry.

b. Project background.

CDER is charged with overseeing the review and approval of human drug products to ensure that they are safe, effective, meet established quality standards, and are available to patients according to their intended use. Currently, CDER has a broad variety of systems and business processes that facilitate the gathering of information from multiple sources to facilitate planning and implementation of risk management and safety monitoring of drugs after they are approved. CDER, and the Agency overall, are still lacking in efforts to harmonize and track safety signals, assessment of impacts in the population, and resultant regulatory processes and activities. The Drug Safety Modernization plan is designed to harmonize processes for identifying, tracking and reporting drug safety activities.

The effort to modernize safety monitoring processes will help maintain and advance CDER’s global leadership, and better support a deeply committed staff. Both science and technology are changing at a blistering pace, and the need for new technologies is critical. This task order will provide Project Management, Business Analyst and System Configuration support for the informatics needs spearheaded by the Office of Business Informatics (OBI).

CDER OBI awarded a task order to Deloitte to support this work utilizing the FDA Safety and Innovation Act (FDASIA) Support BPA. The BPA was competed and is a multiple award BPA with four vendors awarded. The task order that will be modified was competed amongst the four BPA awardees with Deloitte being selected to perform the work. This task order is in its Option year period and CDER OBI has the need to increase the level of effort with the addition of one new use case. The existing Contract and Task Order number is: HHSF223201610018B/75F40120F19007 and the period of performance is 03/27/2021 - 03/26/2022. The total current value of this task order between the base and option year is $3,998,285.48.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title.

Drug Safety WFM Initiatives

b. Project Description.

As referenced in the Drug Safety WFM Initiatives SOW, the scope of this task order covers a CDER-wide implementation and transformation of the Safety Monitoring Modernization effort as a Time and Materials type task order with a six (6) month base period and one (1) twelve (12) month option period specifically utilizing the BPA work scope in task areas C.2 Business Process and Continuous Improvement, C.4 Scientific Study, Knowledge Management, and Planning, and C.5 Communications, Organizational Alignment and Training.

The scope of this order includes end to end implementation and transformation of work processes that support mandated performance goals and commitments, in addition to a variety of other key business processes performed by the Center. The Offeror will leverage existing capabilities that form the basis of CDER’s Informatics Platform. Additionally, the Offeror will extend the CDER Informatics Platform range of operations by studying and gathering requirements from all relevant CDER offices, documenting business processes, configuring COTS software solutions, developing custom solutions, training users on new solutions and providing continuous support for implemented solutions throughout the period of performance of the order. The Offeror will engage in business process analysis and reengineering, requirements analysis, testing, etc. to ensure the delivery of solutions that meet end users’ needs.

Requirement type.

☐ Research & Development (R&D)

☐ R&D support services

☐ Support services (non-R&D)

☐ Supplies/equipment

☒ Information Technology (IT)

☐ Construction

☐ Architect-Engineer (A&E) services

☐ Design-build

☐ Other:

Type of action.

☐ New requirement

☒ Follow-on

☐ Other:

Proposed contract/order type.

☐ Firm-fixed-price

☐ Other fixed-price:

☐ Cost-plus-fixed-fee

☐ Other cost reimbursement:

☒ Time and materials

☐ Indefinite delivery:

☐ Other:

☐ Completion Form

☐ Term Form

Acquisition identification number.

Drug Safety WFM Initiatives

c. Total estimated dollar value and performance/delivery period.

It is anticipated that the requirement will result in an increase of $522,498.40, updating the total from $3,998,285.48 to $4,520,783.88. The current contract has a period of performance of 03/27/2021 – 03/26/2022.

4. Identification of the statutory authority and supporting rationale ( see FAR 8.405-6(a)(1)(i); (b)(1) permitting limited source justification. Check the applicable block below based on the acquisition circumstance.

Federal Acquisition Regulation (FAR):

☒ This acquisition is conducted under the authority of the Multiple Award Schedule Program. In accordance with Federal Acquisition Regulation (FAR) 8.405-6(a), consideration of schedule contractors will be restricted to fewer than the number required at FAR 8.405-1, FAR 8.405-2, FAR 8.405-3 (i.e., fewer than three FSS contractors). FAR 8.405-6 (a)(1)(i), for a proposed order https://www.acquisition.gov/?q=/browse/far/8 https://www.acquisition.gov/?q=/browse/far/8 https://www.acquisition.gov/?q=/browse/far/8 https://www.acquisition.gov/?q=/browse/far/8 or BPA with an estimated value exceeding the micro-purchase threshold not placed or established in accordance with the procedures in FAR 8.405-1, FAR 8.405-2, or FAR 8.405-3, the only circumstances that may justify the actions are-

☐ (A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays;

☐ (B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

☒ (C) In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order or BPA must not have been previously issued under sole-source or limited-sources procedures.

☐ This acquisition is conducted under the authority of the Multiple Award Schedule Program.

In accordance with FAR 8.405-6(b), consideration of schedule contractors will be restricted only to the item peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer. A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer.

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Deloitte & Touche L.L.P 28772 1919 Lynn St Arlington, VA 22209-1742

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

This work is already being performed by Deloitte on this Drug Safety WFM task order and this additional use case aligns tightly to that effort. The tasks to be completed in support of this one additional use case are identical to those being performed currently. To compete this effort and award the development of the use case to a second vendor would create confusion on which vendor is doing what work, and how would we split establishing lines of responsibility between two vendors who are essentially performing the same tasks. Separating this use case from the current work would potentially result in performance issues as the work is logically coupled. Deloitte was originally awarded this effort based on a stronger technical approach and their resources having the best suited skills and experience to successfully accomplish this work.

6. Description of the market research conducted among schedule holders and the results, or a statement of the reasons market research was not conducted.

Extensive market research was conducted for the FDASIA BPA. The market research identified a number of capable contractors. The BPA was competed with four vendors receiving awards: Deloitte, BAH, KPMG and Accenture. However, similar work is already being performed by Deloitte on their Drug Safety WFM task order and this work aligns tightly to that effort. To compete this effort and award the development of the use case to a second vendor would create confusion on which vendor is doing what work, and how would we split establishing lines of responsibility between two vendors who are essentially performing the same tasks. Separating this use case from the current work would potentially result in performance issues as the work is logically coupled. Deloitte was originally awarded this effort based on a stronger technical approach and their resources having the best suited skills and experience to successfully accomplish this work.

Adding the additional use case to the current Deloitte task order is a logical fit as the work is closely related. However, moving forward all new requirements will continue to be competed on the FDASIA BPA. The request for quote was provided to all four BPA holders, Deloitte, BAH, Accenture and KPMG.

With Deloitte and BAH submitting quotes.

7. Determination by the ordering activity Contracting Officer that the order represents the best value consistent with FAR 8.404(d).

The GSA has already determined the prices under FSS contracts, including rates for services offered at fixed hourly rates, to be fair and reasonable; and by placing an order against a schedule contract using the procedures in FAR 8.405-1, the ordering activity CO has concluded that the order represents the best value (see FAR 2.101) and results in the lowest overall price alternative.

The modification is to an existing order under a multiple award GSA BPA. Discounts were already sought. The price evaluation will consist of reviewing the proposed labor categories to perform the work and the estimated hours to complete it to determine the level of effort and the mix of labor proposed to perform the specific task being ordered, and for determining that the total price is reasonable

The contracting officer will use appropriate and available information to review proposed cost/price and determine that it is fair and reasonable. The contracting officer may use a variety of established techniques, including published commercial pricing, historical information, Independent Government Cost Estimates (IGCEs), the current competed BPA rates and any other appropriate costing methods necessary to make the determination. The modification will utilize rates from competed BPA.

8. Any other facts supporting the use of other than full and open competition.

This work is already being performed by Deloitte on this Drug Safety WFM task order and this additional use case aligns tightly to that effort. The tasks to be completed in support of this one additional use case are identical to those being performed currently. To compete this effort and award the development of the use case to a second vendor would create confusion on which vendor is doing what work, and how would we split establishing lines of responsibility between https://www.acquisition.gov/?q=/browse/far/8 https://www.acquisition.gov/?q=/browse/far/2 two vendors who are essentially performing the same tasks. Separating this use case from the current work would potentially result in performance issues as the work is logically coupled.

Deloitte was originally awarded this effort based on a stronger technical approach and their resources having the best suited skills and experience to successfully accomplish this work.

Another major concern is if this work was competed and went to a new vendor, there will be significant delays to even beginning the work as the onboarding process for a new contractor is taking anywhere from 8-12 weeks on average which may also result in an under burn and inability to meet all the required tasks in the necessary timeframe. On top of that, there is a major learning curve and the need for some employees to get elevated admin accounts and we are looking at months before work could really commence. Awarding this work to a new vendor would also create duplication of efforts such as project management oversight and requirements gathering which would in turn cost the government twice as much for the same effort.

Adding the additional use case to the current Deloitte task order is a logical fit as the work is closely related. However, moving forward all new requirements will continue to be competed on the FDASIA BPA. The request for quote was provided to all four BPA holders, Deloitte, BAH, Accenture and KPMG. With Deloitte and BAH submitting quotes. Competing this action would cause significant delays and if another vendor were to be awarded this work, the onboarding process itself would cause additional delays as well as the necessary time to understand the requirements. The period of performance will align with the period of performance currently on this order as there is sufficient time remaining to accomplish this work.

9. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

The BPA was competed with four vendors receiving awards: Deloitte, BAH, KPMG and Accenture. All new orders will be competed amongst the BPA holders.

10. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

The Drug Safety Task Order will be recompeted in FY22 as the vehicle that task order is on has expired.

As we move forward, requirements will be reassessed to determine if the needs are the same or if they have changed significantly. Once requirements have been determined and possibly consolidated, and a new SOW is drafted, it will be competed fairly on the most appropriate existing contract vehicle.

11. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for limiting sources, are accurate and complete.

Signature:____________________________________

Monica Lathan

COR/Requiring Activity POC

Nalan Aksit COR/POC Immediate Supervisor

Urvi Shah on behalf of Sri Mantha Head of the Sponsoring Program Office

12. Contracting Officer Certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Nick Sartain Contracting Officer

13. Supervisory Contracting Officer

One level above CO.

Regina Williams Supervisory Contracting Officer